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<TITLE>NOT-AA-21-009: Notice of Clarification of Research Priorities for RFA-AA-21-002 "SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed) "</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Notice of Clarification of Research Priorities for RFA-AA-21-002 "SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed) " NOT-AA-21-009. NIAAA">
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<META NAME="Keywords" CONTENT="NOT-AA-21-009: Notice of Clarification of Research Priorities for RFA-AA-21-002 "SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed) "">
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<span class="title">Notice of Clarification of Research Priorities for RFA-AA-21-002 "SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed) "</span>
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Notice Number:
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<div data-element-id="1723" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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<span class="noticenum">NOT-AA-21-009</span>
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<a name="_Key_Dates"></a><h2 class="heading2">Key Dates</h2>
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Release Date:
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<p class="Normal">March 23, 2021</p>
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<a name="_"></a><h2 class="heading2">Related Announcements</h2>
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<p class="Normal"><a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-21-002.html"><u>RFA-AA-21-002 </u></a> - SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed)</p>
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</div>
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<a name="_"></a><h2 class="heading2">Issued by</h2>
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</div>
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<p>National Institute on Alcohol Abuse and Alcoholism (<a href="https://www.niaaa.nih.gov/" target="_blank">NIAAA</a>)
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</div>
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<a name="_"></a><h2 class="heading2">Purpose</h2>
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<p class="Normal">The purpose of this notice is to clarify the Research Priorities, by including rural populations, and to emphasize the contextual research relevance to U.S., for projects relying on data or cohorts outside of the U.S. in <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-21-002.html">RFA-AA-21-002 </a>"SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trial Not Allowed)"</p>
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<p class="Normal">The following Sections of <a href="https://grants.nih.gov/grants/guide/rfa-files/RFA-AA-21-002.html">RFA-AA-21-002</a> have been modified to reflect these changes</span></span>:</p>
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<p class="heading4">Part 2. Section I. Funding Opportunity Description</p>
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<p class="Normal"><strong>Research Priorities </strong>(changes between current and revised versions are highlighted in<strong> <em>bold italic</em>s</strong>)</p>
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<p class="Normal"><u>Currently reads:</u></p>
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<p class="Normal">Research is needed that can inform and enhance the nation’s response to the current pandemic by advancing understanding of the relationships between alcohol consumption and misuse, and COVID-19-related outcomes. NIAAA will support research on risks and outcomes associated with alcohol consumption, SARS-CoV-2 infection, and the COVID-19 pandemic in the general population and among underserved populations, such as racial, ethnic and gender minorities, individuals with low socioeconomic status, and those who are incarcerated or homeless.</p>
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<p class="Normal">Priority areas for consideration include but are not limited to:</p>
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<ul>
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<li class="Normal">Conduct secondary analyses of COVID-19- and alcohol-related datasets.</li>
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<li class="Normal">Determine the influence of alcohol drinking history, patterns, amount, and duration on susceptibility to SARS-CoV-2 infection and COVID-19 prevalence, severity, progression, and outcomes, including post-acute sequelae. If evidence of an adverse impact of alcohol is affirmed, pathophysiological research into the mechanisms of alcohol as a physiological effector, the results of which will inform therapeutic approaches during the current pandemic, are sought.</li>
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<li class="Normal">Determine how alcohol misuse and AUD may contribute to neurological and psychiatric manifestation of COVID-19, such as cognitive impairment, sleep disruption, pain, anxiety, etc.</li>
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<li class="Normal">Characterize changes in alcohol consumption levels and patterns during the pandemic and investigate the pandemic-related causes.</li>
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<li class="Normal">Identify best practices in service delivery and barriers to service delivery during the pandemic, including telehealth and in-person options, across the continuum of care for individuals with AUD and in recovery.</li>
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</ul>
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<p class="Normal">Across topic areas, applicants are strongly encouraged to use measures drawn from one or both of the <a href="https://dr2.nlm.nih.gov/">NIH Public Health Emergency and Disaster Research Response (DR2)</a> and the <a href="https://www.phenxtoolkit.org/index.php" title="Link to Non-U.S. Government Site" Title="Link to Non-U.S. Government Site">PhenX Toolkit</a> . Additionally, applications focusing on vulnerable populations, including but not limited to racial/ethnic minorities, health disparity populations, and individuals with existing medical vulnerabilities conferring increased risk for severe COVID-19 infection, e.g., advanced age, obesity, HIV/AIDS, etc., are especially encouraged.</p>
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<p class="Normal"><b>Applications Not Responsive to this FOA</b></p>
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<ul>
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<li class="Normal">Studies that do not explicitly state the urgency of the proposed work and the need for an expedited review timeline</li>
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<li class="Normal">Projects not addressing the relationship between alcohol- and COVID-19-related outcomes or behaviors</li>
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<li class="Normal"><em><strong>Projects that rely exclusively on data or cohorts outside of the United States</strong></em></li>
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<li class="Normal">Projects that are exclusively qualitative</li>
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<li class="Normal">Studies that propose the collection of study assessments and surveys in the absence of a conceptual model and accompanying analyses that address at least one of the above described scientific areas of interest</li>
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<li class="Normal">Clinical trial applications</li>
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<li class="Normal">Mechanistic and preclinical studies using animal models with end points not directly relevant to human conditions.</li>
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</ul>
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<p class="Normal">Applicants are encouraged to contact a program officer in the relevant area.</p>
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<p class="Normal"><u>Revised to read:</u></p>
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<p class="Normal">Research is needed that can inform and enhance the nation’s response to the current pandemic by advancing understanding of the relationships between alcohol consumption and misuse, and COVID-19-related outcomes. NIAAA will support research on risks and outcomes associated with alcohol consumption, SARS-CoV-2 infection, and the COVID-19 pandemic in the general population and among underserved populations, such as racial, ethnic and gender minorities, individuals with low socioeconomic status, <em><strong>rural populations</strong></em> and those who are incarcerated or homeless.</p>
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<p class="Normal">Priority areas for consideration include but are not limited to:</p>
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<ul>
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<li class="Normal">Conduct secondary analyses of COVID-19- and alcohol-related datasets.</li>
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<li class="Normal">Determine the influence of alcohol drinking history, patterns, amount, and duration on susceptibility to SARS-CoV-2 infection and COVID-19 prevalence, severity, progression, and outcomes, including post-acute sequelae. If evidence of an adverse impact of alcohol is affirmed, pathophysiological research into the mechanisms of alcohol as a physiological effector, the results of which will inform therapeutic approaches during the current pandemic, are sought.</li>
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<li class="Normal">Determine how alcohol misuse and AUD may contribute to neurological and psychiatric manifestation of COVID-19, such as cognitive impairment, sleep disruption, pain, anxiety, etc.</li>
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<li class="Normal">Characterize changes in alcohol consumption levels and patterns during the pandemic and investigate the pandemic-related causes.</li>
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<li class="Normal">Identify best practices in service delivery and barriers to service delivery during the pandemic, including telehealth and in-person options, across the continuum of care for individuals with AUD and in recovery.</li>
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</ul>
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<p class="Normal">Across topic areas, applicants are strongly encouraged to use measures drawn from one or both of the <a href="https://dr2.nlm.nih.gov/">NIH Public Health Emergency and Disaster Research Response (DR2)</a> and the <a href="https://www.phenxtoolkit.org/index.php" title="Link to Non-U.S. Government Site" Title="Link to Non-U.S. Government Site">PhenX Toolkit</a>. Additionally, applications focusing on vulnerable populations, including but not limited to racial/ethnic minorities, health disparity populations, and individuals with existing medical vulnerabilities conferring increased risk for severe COVID-19 infection, e.g., advanced age, obesity, HIV/AIDS, etc., are especially encouraged.</p>
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<p class="Normal"><em><b>Research supported under this FOA is expected to be relevant to the United States. Projects relying on data or cohorts outside of the U.S. must provide a strong justification for the relevance of the research to the U.S. context.</b></em></p>
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<p class="Normal"><b><b>Applications Not Responsive to this FOA</b></b></p>
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<ul>
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<li class="Normal">Studies that do not explicitly state the urgency of the proposed work and the need for an expedited review timeline</li>
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<li class="Normal">Projects not addressing the relationship between alcohol- and COVID-19-related outcomes or behaviors</li>
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<li class="Normal">Projects that are exclusively qualitative</li>
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<li class="Normal">Studies that propose the collection of study assessments and surveys in the absence of a conceptual model and accompanying analyses that address at least one of the above described scientific areas of interest</li>
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<li class="Normal">Clinical trial applications</li>
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<li class="Normal">Mechanistic and preclinical studies using animal models with end points not directly relevant to human conditions.</li>
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</ul>
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<p class="Normal">Applicants are encouraged to contact a program officer in the relevant area<b> <b><em>in the early stages of preparing an application</em></b>.</b></p>
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<p class="Normal" style="list-style-type: disc;"></span></p>
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<p class="Normal">All other aspects of this FOA remain unchanged.</p>
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</div>
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<a name="_"></a><h2 class="heading2">Inquiries</h2>
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<p>Please direct all inquiries to:</p>
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</div>
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<p class="Normal">M. Kathy Jung. Ph.D.<br />
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)<br />
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Telephone: 301-443-8744<br />
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Email: <a><span class="__cf_email__" data-cfemail="b8d2cdd6dfd5d9f8d5d9d1d496d6d1d096dfd7ce">[email protected]</span></a></p>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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